Regulatory Affairs Assistant

Teva Pharmaceuticals • Miramar, FL

32d • Onsite

About The Position

The Regulatory Affairs Assistant is responsible for providing administrative support, generation and facilitation of regulatory documents in accordance with federal regulations, ICH Guidelines, good Clinical Practices (GCPs) and WTI Standard Operating Procedures (SOPs).

Requirements

• High school Diploma or GED equivalent required
• A minimum of one (1) year of clinical research experience, regulatory experience is preferred
• Possesses an understanding of medical terminology and the application of scientific/medical and clinical concepts to conduct clinical trials
• Possesses an understanding of GCPs and federal regulations
• Possesses strong organizational and time management skills
• Excellent interpersonal, organizational, and time-management skills
• Able to work under extremely tight deadlines
• Strong analytical and decision making skills
• Able to coordinate workloads to meet extremely tight deadlines
• Possesses exceptional customer service and public relations skills, professionalism, and the ability to communicate effectively with internal and external parties
• Proficient in MS Office Suite (Word, Excel, Outlook, PowerPoint)
• Able to speak, read, and write fluent English required

Nice To Haves

• Bachelor's Degree preferred
• Able to speak, read and write fluent in Spanish preferred

Responsibilities

• Conducts all regulatory activities in accordance with Institutional Review Board (IRB) guidelines, Good Documentation Practices (GDPs), Good Clinical Practice (GCP) standards, Standard Operating Procedures (SOP’s), Quality procedures (QA/QC), OSHA guidelines and other state and local regulations as applicable, ensuring strict compliance to the study protocol at all times
• Generates, facilitates and maintains all study related regulatory documents from pre-study through study close out, ensuring quality, accuracy, and timeliness
• Serves as site support on Institutional Review Board (IRB) processes
• Maintains regulatory documents according to GCP, ICH, FDA, and Sponsor requirements
• Prepares and maintains records for archiving and/or retrieval
• Acts as a liaison between internal departments, Sponsors, and IRBs to ensure quality, accuracy and timely turnaround of regulatory documents
• Reviews all regulatory documents prior to Sponsor/Monitor/Regulatory Authority visits
• Participates as a supporting member of the study and site team
• Provides support and assistance as needed by the organization

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED